BEUDAMED
    FDA Adverse Event Summary report: N

    FIRST CHOICE TEST STRIP

    MDR report key: 13040 · Received April 22, 1994

    Report

    Report Number
    MW4000369
    Date Received
    April 22, 1994
    Report Date
    April 6, 1994
    Manufacturer
    POLYMER TECH INTL.
    Product Code
    CFR
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR NOTED THAT WHILE USING THIS PRODUCT HIS RANGES HAVE BEEN CONSISTENTLY HIGHER THAN WHEN HE HAD USED ANOTHER CO'S TEST STRIPS. THE RANGES WERE 315, 280 AND 184 WHEN USING THE STRIPS AND 243, 237 AND 117 WHEN USING THE OTHER CO'S STRIPS. RPTR HAD CONTACTED THE PLACE OF PURCHASE AND THEY NOTED THAT THERE WERE OTHER REPORTS OF THIS SAME PROBLEM TO THEIR PHARMACY. THE NORMAL RANGE IS 110-167.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST CHOICE TEST STRIP CFR POLYMER TECH INTL. E18053

    Patients

    Seq Age Sex Outcome Treatment
    1 *